MK-0646, Etoposide, and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

NCT00869752 | Completed Phase 1 DMC

• 3 other identifiers: I190CAN-NCIC-IND190CDR0000634447
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Monoclonal antibodies, such as MK-0646, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of MK-0646 when given together with etoposide and cisplatin and to see how well it works in treating patients with extensive-stage small cell lung cancer.

Conditions

Lung Cancer

Keywords

combined type small cell lung cancer; fusiform type small cell lung cancer; polygonal type small cell lung cancer; lymphocyte-like type small cell lung cancer; extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (5)

• Recommended phase II dose of MK-0646 in combination with standard etoposide and cisplatin chemotherapy

  Evaluate safety, tolerability in combination with standard chemotherapy.

  Each dose level

• Toxicity and tolerability according to NCI CTCAE v3.0

  Look at toxicity and tolerability of MK0646 in combination with standard therapy.

  Phase 1, each dose level and Phase II

• Preliminary efficacy

  Look for evidence of response

  Phase 1 dose levels, evey other cycle

• Objective response rate

  Determine objective response rate including complete response rate, progression free survival and overall survival.

  Phase II portion, every other cycle

• Predictive and prognostic impact of biomarkers

  Blood samples will be collected and analyzed for occurrence of human-anti-humanized antibody response to MK0646 as well as IGF-1R analysis.

  Each cycle

Study Arms (1)

Arm 1

EXPERIMENTAL

MK-0646, a monoclonial antibody in combination with etoposide and cisplatin.

Biological: anti-IGF-1R recombinant monoclonal antibody MK-0646; Drug: cisplatin; Drug: etoposide

Interventions

anti-IGF-1R recombinant monoclonal antibody MK-0646 BIOLOGICAL

MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days

Arm 1

cisplatin DRUG

MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days

Arm 1

etoposide DRUG

MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer (SCLC) * Extensive stage disease that is incurable but amenable to treatment with platinum-based chemotherapy * Small cell and variant histologies allowed * No mixed tumors (i.e., small and large cell) or other neuroendocrine tumors of the lung * Clinically and/or radiologically documented measurable disease, defined as ≥ 1 unidimensionally measurable site of disease ≥ 20 mm by chest x-ray, ≥ 15 mm by CT scan (lymph nodes), or ≥ 10 mm by CT scan or physical exam * No uncontrolled or symptomatic CNS metastases * Patients who have completed radiotherapy or have undergone complete resection of CNS metastases are allowed provided they are on stable (non-increasing) or decreasing doses of corticosteroids PATIENT CHARACTERISTICS: * Life expectancy ≥ 12 weeks * ECOG performance status 0-2 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN (≤ 5 times ULN if documented liver metastases) * Serum creatinine ≤ ULN OR creatinine clearance ≥ 50 mL/min * Not pregnant or lactating * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy * No other active cancer * No untreated and/or uncontrolled cardiovascular or other comorbid conditions * Patients with a significant cardiac history, even if controlled, should have a LVEF \> 50% * No uncontrolled diabetes * Must be accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior cytotoxic chemotherapy or other IGF-1R targeting agents for SCLC * At least 3 weeks since prior radiotherapy to neurological sites * No prior radiotherapy to the lungs * Prior surgery allowed provided that wound healing has occurred * At least 14 days since prior major surgery * No other concurrent investigational agents or therapy * No other concurrent anticancer treatment * No concurrent radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• Merck Frosst Canada Ltd.: collaborator

Study Sites (3)

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• J Clin Oncol 30, 2012 (suppl; abstr 7093)

  RESULT

• Ellis PM, Shepherd FA, Laurie SA, Goss GD, Olivo M, Powers J, Seymour L, Bradbury PA. NCIC CTG IND.190 phase I trial of dalotuzumab (MK-0646) in combination with cisplatin and etoposide in extensive-stage small-cell lung cancer. J Thorac Oncol. 2014 Mar;9(3):410-3. doi: 10.1097/JTO.0000000000000058.

  PMID: 24518092 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

dalotuzumab; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Peter Ellis, MD

  Margaret and Charles Juravinski Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: December 16, 2009
• Primary Completion: March 15, 2012
• Study Completion: July 4, 2012
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)